Blog — Notes of a Plastic Surgeon

Welcome to my blog. I am a plastic surgeon in Seattle and have been in private practice since 1991. I've seen more than a few interesting faces and cases through my years spent in the exam room, the operating room and the emergency room. And I have an opinion on just about everything relating to plastic surgery (and a lot of unrelated stuff). If you like my blog, let me know. Thanks for reading! Lisa

Maximizing Follow-Up in Cosmetic Surgery Clinical Trials – Money Helps

In a previous blog post bemoaning the difficulty of good follow-up in clinical research I sort of place most of the blame on patients who blow off the follow-up  once they have their desired implants.  This was my experience with the implant study I participated in many years ago.  I had an 80% follow-up at 5 years (which was really, really high)  mostly because I pestered patients relentlessly to come back for their follow-up exams.  I have taken a bit of flack (especially from the breast implant illness activists) for my blame-the-patient stance but now there is a recent study out that supports my politically incorrect opinion.  Check this out.  It seems if you pay the patient big bucks to show up they do!  This study has an astounding 94.9% and 96.7% follow-up compliance at 5 years.  The study has another 5 years to go and my guess is that given the size of the monetary award, those numbers will also be very high.

“Maybe I will show up for my follow-up.”

Novel Approach for Maximizing Follow-Up in Cosmetic Surgery Clinical Trials: The Ideal Implant Core Trial Experience

Mueller, Melissa A. M.D.; Nichter, Larry S. M.D.; Hamas, Robert S. M.D.

Plastic and Reconstructive Surgery: October 2017 – Volume 140 – Issue 4 – p 706–713
Cosmetic: Original Articles
Background: High follow-up rates are critical for robust research with minimal bias, and are particularly important for breast implant Core Studies seeking U.S. Food and Drug Administration approval. The Core Study for IDEAL IMPLANT, the most recently U.S. Food and Drug Administration–approved breast implant, used a novel incentive payment model to achieve higher follow-up rates than in previous breast implant trials.

Methods: At enrollment, $3500 was deposited into an independent, irrevocable trust for each of the 502 subjects and invested in a diversified portfolio. If a follow-up visit is missed, the subject is exited from the study and compensated for completed visits, but the remainder of her share of the funds stay in the trust. At the conclusion of the 10-year study, the trust will be divided among those subjects who completed all required follow-up visits. For primary and revision augmentation cohorts, the U.S. Food and Drug Administration published follow-up rates from Core Studies were compared for all currently available breast implants.

Results: Five-year follow-up rates for the IDEAL IMPLANT Core Study are higher for both primary augmentation and revision augmentation cohorts (94.9 percent and 96.7 percent, respectively) when compared to all other trials that have used U.S. Food and Drug Administration standardized follow-up reporting (MemoryShape, Allergan 410, and Sientra Core Studies).

Conclusions: This trial demonstrates the utility of a novel incentive strategy to maximize follow-up in cosmetic surgery patients. This strategy may benefit future cosmetic surgery trials and perhaps any prospective research trial by providing more complete data.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Hey, thanks for reading and I really thank Drs. Mueller, Nichter and Hamas for this awesome article.  And my hat is really off to Dr. Robert Hamas who not only thought up the idea of the Ideal implant but actually brought it to market.  And Ideal only sells its implants to surgeons certified by the American Board of Plastic Surgery.  That means if your surgeon is using an Ideal implant, he/she is actually a real honest to goodness plastic surgeon, not just poseur.

And I would be honored if you followed me on Instagram @sowdermd and @breastimplantsanity. Dr. Lisa Lynn Sowder

 

Category: Breast Implant Illness, Breast Implants, New Technology, Now That's Cool | Tags: , , , , , , , ,

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